Label: COLGATE ANTICAVITY KIT- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 56153-002-05, 56153-002-10
- Packager: Ming Fai Industrial (Shenzhen) Co. Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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- Active ingredient
- Purpose
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- Warnings
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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INGREDIENTS AND APPEARANCE
COLGATE ANTICAVITY KIT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56153-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) LIMONENE, (+/-)- (UNII: 9MC3I34447) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56153-002-05 1 in 1 PACKAGE 05/10/2013 1 5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:56153-002-10 1 in 1 PACKAGE 05/10/2013 2 10 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/10/2013 Labeler - Ming Fai Industrial (Shenzhen) Co. Ltd (527078784) Registrant - Ming Fai Industrial (Shenzhen) Co. Ltd (527078784) Establishment Name Address ID/FEI Business Operations Ming Fai Industrial (Shenzhen) Co. Ltd 527078784 manufacture(56153-002) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive Company 672044552 manufacture(56153-002)